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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-2062

2. Registrant Information.

Registrant Reference Number: M-057895-01-1

Registrant Name (Full Legal Name no abbreviations): Bayer CropScience Inc.

Address: Suite 200, 160 Quarry Park Blvd S.E.

City: Calgary

Prov / State: Alberta

Country: Canada

Postal Code: T2C 3G3

3. Select the appropriate subform(s) for the incident.

Scientific Study

4. Date registrant was first informed of the incident.

5. Location of incident.

6. Date incident was first observed.

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

PMRA Registration No. 28428      PMRA Submission No.       EPA Registration No.

Product Name: THIACLOPRID TECHNICAL INSECTICIDE

  • Active Ingredient(s)
    • THIACLOPRID

7. b) Type of formulation.

Application Information

8. Product was applied?

Unknown

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform VII: Scientific Study

1. Study Reference

Title ACUTE SKIN IRRITATION TEST (PATCH TEST) OF YRC 2894 240 OD IN RABBITS

Date 09-SEP-02

2. a) Is an extension needed to translate the document?

No

3. Type of incident identified in the study

Increased health or environmental risk

4. Describe the incident identified in the study (e.g. study demonstrates an increased risk to non-Hodgkin's Lymphoma after exposure to pesticide X)

A 240 OD formulation of thiacloprid caused moderate skin irritation including erythema up to 8 days after patch removal and skin induration up to 5 days after patch removal. This formulation is not registered in Canada.

5. a) Was the study discontinued before completion?

No

5. b) Provide the reason for discontinuation

6. If the study is ongoing, what is the expected completion date?

For Registrant use only

7. Provide supplemental information here

Calypso 480 SC is the only registered formulation of thiacloprid in Canada and does not cause skin irritation. However, under the current adverse effects reporting requirements in Canada, we are required to submit any data on formulations showing an adverse effect regardless of whether or not the formulation is registered in Canada.